Cvrx, Inc. Stock Price, News & Analysis

CVRx, a medical device company, announced preliminary results from the BeAT-HF trial at the THT conference on March 21, 2023. Conducted on the Barostim device, these results showed a 97% rate of major adverse events, with significant long-term improvements in patient outcomes. The device led to a 34% reduction in all-cause mortality compared to control, and a win ratio of 1.26 favoring Barostim. The data supports Barostim as a safe and effective therapy for heart failure. CVRx plans to submit this data to the FDA for expanded labeling and anticipates publication of full results in peer-reviewed journals.

CVRx, a medical device company specializing in neuromodulation for cardiovascular diseases, announced plans to present preliminary results from the BeAT-HF trial at the Technology and Heart Failure Therapeutics (THT) conference on March 21, 2023. Dr. Michael Zile from MUSC will present these results. The company will also sponsor a symposium titled 'Baroreflex Activation Therapy in HFrEF: New Insights from the BeAT-HF Study' during the conference. Subsequently, CVRx will hold an investor conference call at 4:30 pm ET to discuss the results. Barostim™, their FDA-approved device, aims to alleviate heart failure symptoms through autonomic balance restoration.

CVRx announced preliminary results from the BeAT-HF trial, assessing the Barostim device for heart failure treatment. The trial included 323 patients, comparing Barostim + medical therapy to medical therapy alone. While the primary endpoint was not statistically significant, additional analyses indicated potential benefits, including improved all-cause survival and quality of life. The safety profile of Barostim remained robust over 24 months. CVRx intends to submit these findings to the FDA for expanded labeling. The results will be discussed in a conference call on February 21, 2023, and presented at the THT Conference on March 21, 2023.

CVRx reported a remarkable 96% increase in fourth-quarter revenue, totaling $7.2 million compared to the previous year. Heart Failure (HF) revenue surged 121% to $6.0 million, driven by expansion into new territories and heightened awareness of Barostim. Total 2022 revenue reached $22.5 million, up 72%. The number of active implanting centers rose from 46 to 106, a 130% increase. However, the company faced a net loss of $10.5 million in Q4. For 2023, CVRx anticipates total revenue between $35 million and $38 million and gross margins of 78%-79%.

CVRx, Inc. plans to release its fourth quarter and full year 2022 financial results after market close on January 26, 2023. A conference call will follow at 5:30 p.m. Eastern Time to discuss the results, which will be available via webcast. CVRx focuses on innovative neuromodulation solutions for cardiovascular diseases, specifically the Barostim device, the first FDA-approved technology using neuromodulation to treat heart failure symptoms. Barostim has received FDA Breakthrough Device designation and is CE Mark approved for additional indications.

CVRx, Inc. announced preliminary unaudited revenue results for Q4 and full year 2022. Q4 revenue is estimated between $7.0M and $7.1M, up approximately 91% to 94% from Q4 2021. Full year 2022 revenue is anticipated to be $22.3M to $22.4M, a 71% to 72% increase from 2021. The company reported 106 active implanting centers and expects 2023 revenue between $35.0M and $38.0M with gross margins of 78% to 79%. Cash reserves stood at $106 million as of December 31, 2022.

CVRx, a medical device company focused on neuromodulation solutions for cardiovascular diseases, will present at the 41st Annual J.P. Morgan Healthcare Conference on January 11, 2023, at 3:45 pm Pacific Time. The presentation will be available via a live audio webcast, with a replay accessible for 30 days. CVRx's flagship product, Barostim, is an FDA-approved device designed to reduce heart failure symptoms by improving autonomic nervous system balance through electrical pulses to baroreceptors in the carotid artery. For more details, visit ir.cvrx.com.

CVRx, Inc. announced the appointment of Kevin Hykes to its Board of Directors effective December 21, 2022. Hykes brings over 30 years of experience in the medical device sector, having held leadership roles in several companies, including Augmedics and Bardy Diagnostics. His expertise is expected to bolster CVRx's efforts to enhance the global reach of Barostim™, a neuromodulation device aimed at improving heart failure symptoms. The management expresses optimism regarding the impact of Hykes' leadership on the company's growth trajectory.

CVRx, a medical device company focused on neuromodulation solutions for cardiovascular diseases, will participate in the Piper Sandler 34th Annual Healthcare Conference on November 30, 2022, at 8:00 am Eastern Time. The presentation will be available via a live audio webcast on the company’s investor relations page. CVRx’s primary product, the Barostim™ System, is the first FDA-approved medical technology using neuromodulation to alleviate heart failure symptoms. The device has received FDA Breakthrough Device designation and CE Mark approvals for heart failure and resistant hypertension.